Phase 2
Completed N=21
Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI
Bone Cancer · Chondrosarcoma · Ewing's Sarcoma · Osteosarcoma
Source: ClinicalTrials.gov NCT01336803 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects — 7.3; 7.7 milliseconds
Summary
This pilot trial studies the differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI). Imaging procedures that allow doctors to more accurately differentiate between malignant bone sarcomas and osteomyelitis may help in diagnosing patients correctly and may result in more timely treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects |
7.3; 7.7 | — |
| SECONDARY Differentiation of Bone Sarcomas Pre-ferumoxytol and Post-ferumoxytol Contrast |
13.80; 8.27 | — |
| SECONDARY Differentiation of Lymphoma and Bone Sarcomas With Ferumoxytol-enhanced MRI |
14.83; 7.71 | — |
| SECONDARY Differentiation of CD68-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas |
4.8; 6.1 | — |
| SECONDARY Differentiation of CD163-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas |
1.9; 9.4 | — |
Eligibility Criteria
INCLUSION CRITERIA
- Age 10 to 21 years
- Suspected or confirmed diagnosis of a bone sarcoma or osteomyelitis
- Informed consent with assent as appropriate.
EXCLUSION CRITERIA
- Contraindication to MRI
- Presence of metal implants
- Need for sedation or anesthesia
- Claustrophobia
- Hemosiderosis or hemochromatosis
- History of allergic reactions to similar compounds will be obtained and patients with positive history of allergic reactions will be excluded from the study
- Females who are pregnancy or nursing
Data sourced from ClinicalTrials.gov (NCT01336803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.